Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA (CARMEN-LC06)
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|ClinicalTrials.gov Identifier: NCT05245071|
Recruitment Status : Recruiting
First Posted : February 17, 2022
Last Update Posted : January 11, 2023
This is an open label single group, Phase 2, 1-arm study for treatment to evaluate efficacy, safety, and Pharmacokinetic (PK) of tusamitamab ravtansine in nonsquamous non-small-cell-lung-cancer (NSQ NSCLC) participants with negative or moderate CEACAM5 expression tumors and high circulating carcinoembryonic antigen (CEA).
Participants who will be enrolled, will receive tusamitamab ravtansine as monotherapy every two weeks (Q2W) until disease progression, unacceptable adverse event (AE), initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment, whichever comes first. A total of approximately 38 participants are planned to be treated.
|Condition or disease||Intervention/treatment||Phase|
|Non-squamous Non-small Cell Lung Cancer||Drug: Tusamitamab ravtansine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label, Phase 2 Study, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine in Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA|
|Actual Study Start Date :||June 3, 2022|
|Estimated Primary Completion Date :||February 2, 2024|
|Estimated Study Completion Date :||May 24, 2024|
Experimental: Tusamitamab ravtansine
Tusamitamab ravtansine dose will be administered on Day 1 via IV infusion and repeated once every 2 weeks. The duration of 1 cycle will be 14 days (1 administration of tusamitamab ravtansine per cycle).
Drug: Tusamitamab ravtansine
Pharmaceutical Form: Concentrate for solution Route of Administration: Intravenous infusion
Other Name: SAR408701
- Objective Response Rate (ORR) [ Time Frame: Baseline up to approximately 9 months after last patient treated ]Objective Response Rate (ORR), defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) as best overall response (BOR) per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
- Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities [ Time Frame: Baseline up to approximately 90 days after the last study treatment administration ]Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
- Progression-free survival (PFS) [ Time Frame: Baseline up to approximately 9 months after last patient treated ]PFS defined as the time from the date of first tusamitamab ravtansine administration to the date of the first documented disease progression or death due to any cause, whichever comes first.
- Disease control rate (DCR) [ Time Frame: Baseline up to approximately 9 months after last patient treated ]DCR defined as the percentage of participants who have achieved confirmed CR or PR, or stable disease as BOR per RECIST v1.1
- Duration of response (DOR) [ Time Frame: Baseline up to approximately 9 months after last patient treated ]DOR, defined as the time from first documented evidence of CR or PR until progressive disease (PD) determined per RECIST v1.1 or death from any cause, whichever occurs first
- Incidence of participants with anti-therapeutic antibodies (ATAs) against tusamitamab ravtansine [ Time Frame: Baseline up to approximately 30 days after the last study treatment administration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05245071
|Contact: Trial Transparency email recommended (Toll free number for US & Canada)||800-633-1610 ext option 6||Contact-US@sanofi.com|
|Study Director:||Clinical Sciences & Operations||Sanofi|